Hypersomnia in Major Depressive Disorder
1 other identifier
observational
350
1 country
1
Brief Summary
Background: MDD is a common mental disorder with significant morbidities and mortalities. Recent local data suggested that depressive disorders have a prevalence of over 12% in females and nearly 7 % in males in Hong Kong general adult population. Other than insomnia, patients with MDD often complained another sleep symptom - hypersomnia (defined as daytime sleepiness or excessive sleep). Interestingly, when compared to insomnia, there is much far less research on the role of hypersomnia in MDD. However, there are available data suggested that hypersomnia is associated with greater treatment-resistance, more recurrence, and increased suicidality, suggesting a need to investigate this problem in MDD patients. Objective: To investigate the prevalence and determine characteristics of hypersomnia amongst major depressive disorder. Design: 2-phase study design Setting: A case-control study Participants: Patients with a history of Major Depressive Disorder from out-patient clinics in New Territories East Cluster. Main outcome measures: Daytime sleepiness measured by MSLT, actigraphy and self-reported questionnaire (ESS), sleep duration as measured by sleep diary and actigraphy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedSeptember 6, 2019
September 1, 2019
8 months
February 25, 2019
September 3, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Hypersomnia
Daytime Sleepiness measured by self rated Epworth Sleepiness Scale
1 year
Depression severity
Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder (SIGH-SAD)
1 year
Secondary Outcomes (2)
Fatigue
1 year
Function as indicated quality of life
1 year
Study Arms (2)
MDD with hypersomnia
Patient with a history of MDD and ESS \>10
MDD without hypersomnia
Patient with a history of MDD and ESS \<=10
Interventions
Eligibility Criteria
Subjects will be successively recruited from August 2018 to August 2019 from the out-patient psychiatric clinics within the New Territories Eastern Cluster.
You may qualify if:
- patients aged between 18-64 years old with a history of MDD
You may not qualify if:
- patients with history of bipolar disorder, schizophrenic-spectrum disorder, substance abuse, alcohol dependence, dementia, patients with history of mental retardation and those unable to give consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang JiHui, Dr
CUHK
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 25, 2019
First Posted
July 5, 2019
Study Start
July 1, 2019
Primary Completion
February 28, 2020
Study Completion
August 31, 2020
Last Updated
September 6, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share